Product Wiki · Recalls · Health Canada — Medical Devices

ArjoHuntleigh Sara 3000, Sara Plus, Tenor, Minstrel (2017-10-31) — recall 57996

Health Canada — Medical Devices · Canada · 2017-11-30 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57996
Date of alert
2017-11-30
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: It has been found that the Sara 3000, Sara plus, Minstrel and Tenor devices have experienced problems with the electrical functions related to the printed circuit board (PCB) losing the safe working load (SWL) settings, resulting in the inconvenience of the device usage. ArjoHuntleigh has decided to perform a PCB software upgrade to eliminate the detected problem.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/arjohuntleigh-sara-3000-sara-p

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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